MAUDE Adverse Event Report: VYAIRE MEDICAL, INC PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number REVEL VENTILATOR

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Hyperventilation (1910); Low Oxygen Saturation (2477)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

Any additional information provided by the customer will be included in a follow up report.A vyaire certified service technician was unable to verify the customer¿s reported issue.The device passed 98.3 hours of extended bench testing, passed initial final test and initial alarm volume test with no abnormalities or alarm conditions.A review of the event trace indicates that the ¿blower demand exceeded alarm¿ condition was preceded by alarm conditions that indicates the presence of a significant patient circuit leak.These preceding alarm conditions include "low ve alarm", "low ppeak alarm", ¿patient circuit fault alarm¿, "low peep alarm" and "high breath rate alarm" which repeatedly trigger then recover along with the "blower demand exceeded alarm" condition.The presence of a patient circuit leak in excess of the 30lpm leak compensation capabilities of the ptv ventilator can result in continuous peak blower operation while the ventilator attempts to meet the breath requirement settings of the patient.The device passed all testing and met all vyaire manufacturer specifications.

Event Description

It was reported to vyaire that the revel ventilator displayed a blower motor alarm while connected to a patient.The customer stated that the patient's oxygen saturation dropped but there were several other factors that potentially played into that.The patient was on bilevel positive airway pressure (bipap) with the low pressure settings utilized by the transport crew.The customer stated that the patient was also very tachypneic.At this time, no further information has been provided regarding the patient's condition.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7233001
• MDR Text Key: 98730429
• Report Number: 2031702-2018-02079
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REVEL VENTILATOR
• Device Catalogue Number: 19260-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention